A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study of NAV-240 in Adult Participants With Moderate-to-Severe Hidradenitis Suppurativa (Mainsail)

NCT07384975 Phase 2 RECRUITING

The main objective of this study is to determine if NAV-240 works more effectively than a dummy treatment (placebo) for participants with moderate-to-severe HS. The main endpoint of this study is the percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 at Week 16, meaning at least a 75% reduction in inflamed skin bumps (abscess and inflammatory nodule (AN) count) with no increase in number of abscesses or draining tunnels (channels under the skin that leak fluid or pus) compared to the baseline (start of the study). Participants will: * Receive NAV-240 dose 1, NAV-240 dose 2 or placebo as a drip into the veins (intravenous infusion). * Visit the clinic up to 9 times for checkups and tests over 22 weeks. * Complete a daily diary about their skin pain.

Details

Lead sponsor	Navigator Medicines, Inc.
Phase	Phase 2
Status	RECRUITING
Enrolment	150
Start date	2026-01-05
Completion	2027-10

Conditions

• Hidradenitis Suppurativa (HS)

Interventions

• NAV-240
• Placebo to match NAV-240

Primary outcomes

• Proportion of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR) 75 — Baseline to Week 16
  HiSCR75 is defined as at least a 75% reduction in total abscess and inflammatory nodule count (AN count) with no increase in abscess count and no increase in draining tunnel count relative to baseline.

Countries

United States